Miniaturized Percutaneous Nephrolithotomy for Kidney Stones

Overseen By Lauren Grimm

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Must not be taking: Anticoagulants

Disqualifiers: Coagulopathy, Renal anomalies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for performing less invasive surgery to remove kidney stones. It compares a vacuum-assisted sheath with a standard sheath to determine which is more effective. Both methods are already used safely for similar kidney stones. Suitable participants have kidney stones between 10-25 mm and already have a tube or stent in place for the procedure. As an unphased trial, this study allows participants to contribute to advancements in kidney stone treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on blood thinners (anticoagulants), you may not be eligible to participate.

What prior data suggests that these mini-PCNL procedures are safe for kidney stone treatment?

Research has shown that both mini-PCNL and vacuum-assisted sheaths are safe for treating kidney stones. Studies indicate that mini-PCNL achieves good results, with success rates comparable to other kidney stone treatments. It remains safe and effective, even for patients with kidney issues.

For vacuum-assisted sheaths, studies suggest they may result in fewer complications and infections compared to standard sheaths. They also appear to remove stones more effectively.

Both treatments are well-tolerated, with research supporting their safety for individuals with kidney stones. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about miniaturized percutaneous nephrolithotomy (PCNL) for kidney stones because it offers a less invasive approach compared to traditional PCNL. This technique uses smaller instruments, which can reduce tissue damage and lead to faster recovery times. Additionally, the vacuum-assisted access sheaths provide a new method for stone removal by actively suctioning out fragments, potentially increasing the efficiency of the procedure. These innovations could mean less pain and quicker recovery for patients, making the treatment an intriguing alternative to existing methods.

What evidence suggests that this trial's procedures could be effective for treating kidney stones?

Research has shown that a procedure called mini-PCNL effectively treats kidney stones, particularly those 1-2 cm in size, with success rates similar to standard treatments. In this trial, participants will be assigned to different treatment arms. One arm will use passive suction via conventional sheaths, while another will use vacuum-assisted sheaths. A study found that vacuum-assisted tools during the procedure improved the chances of being stone-free afterward compared to traditional methods. This suggests that both approaches effectively remove kidney stones, with vacuum-assisted tools possibly offering slightly better results. ^{3 4 6 7 8}

Who Is on the Research Team?

Sriharan Sivalingam

Principal Investigator

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for adults over 18 with kidney stones sized between 10-25 mm, who can consent and meet study requirements. It's open to all ethnicities and genders. Those with a nephrostomy tube or ureteral stent already in place may join. People on blood thinners, with coagulation disorders, congenital kidney anomalies, previous kidney surgeries, or needing multiple access tracts are excluded.

Inclusion Criteria

I am scheduled for a specific kidney stone surgery and had a special CT scan before.

I am willing and able to follow the study's requirements.

It's okay if you already have a tube in your kidney or ureter.

Exclusion Criteria

I have had surgery before on the same side of my upper urinary tract.

I am able to understand and agree to the study's requirements.

My surgery was changed to an open procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo miniaturized percutaneous nephrolithotomy using either a vacuum-assisted or standard sheath

1 day

1 visit (in-person)

Post-operative Hospital Stay

Participants remain in the hospital for recovery and monitoring after the procedure

1-2 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up appointment approximately 4-6 weeks post-surgery

4-6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Sheaths
• Miniaturized Percutaneous Nephrolithotomy
• Vacuum-Assisted Access Sheaths

Trial Overview

The study compares two surgical methods for removing kidney stones: one using a vacuum-assisted sheath and the other using a conventional sheath during mini-PCNL (a minimally invasive surgery). The goal is to determine which method is more effective for patients like you.

How Is the Trial Designed?

Group I: passive suction via conventional sheath Active Control 2 Interventions

Group II: vacuum-assisted sheath Active Control 1 Intervention

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

The mini-PCNL procedure using a 20F sheath demonstrated a high single-procedure stone-free rate of 90% among 21 patients, indicating its efficacy in treating kidney stones.

Using a smaller 20F sheath reduced the volume of renal tissue affected by 56%, leading to less bleeding, reduced pain, and minimized scarring compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minipercutaneous nephrolithotomy. Monga, M., Oglevie, S.[2022]

In a study of 84 patients undergoing different types of percutaneous nephrolithotomy (PCNL), the ultra-mini PCNL (um-PCNL) resulted in the least hemoglobin drop, indicating better safety in terms of blood loss compared to standard (s-PCNL) and mini PCNL (m-PCNL).

While um-PCNL had a longer operation time, it required a shorter hospital stay than both s-PCNL and m-PCNL, suggesting it may be a more efficient option for patients with lower stone burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between standard, mini and ultra-mini percutaneous nephrolithotomy for single renal stones: a prospective study. Adamou, C., Goulimi, E., Pagonis, K., et al.[2022]

In a study of 80 pediatric patients undergoing percutaneous nephrolithotomy (PCNL) for stones less than 25 mm, both the ultra-mini 12 Fr sheath and the mini 16 Fr sheath showed similar high success rates for stone clearance (97.5% vs. 95.0%).

The procedure using the 16 Fr sheath was completed significantly faster (24.5 minutes) compared to the 12 Fr sheath (34.6 minutes), with no notable differences in complications or bleeding between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mini versus ultra-mini percutaneous nephrolithotomy in a paediatric population. Mishra, DK., Bhatt, S., Palaniappan, S., et al.[2022]

In a study of 136 patients, vacuum-assisted percutaneous nephrolithotomy (Va-PCNL) demonstrated a significantly shorter operative time (95 minutes) compared to standard mini-PCNL (146 minutes), making it a more efficient option for kidney stone treatment.

Both Va-PCNL and mini-PCNL had similar stone-free rates (around 72%) and complication rates, but Va-PCNL resulted in a shorter hospital stay (1.7 days vs. 2.7 days), indicating it may offer advantages in recovery time without compromising safety or efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum-assisted access sheath in supine mini-percutaneous nephrolithotomy (mini-PCNL). Szczesniewski, JJ., Boronat Catalá, J., García-Cano Fernández, AM., et al.[2023]

The miniaturized nephrolithotomy (mini-perc) technique achieved a high stone-free rate of 90.1% after one procedure and 98% after additional treatment, making it an effective option for managing renal stones smaller than 20 mm.

This minimally invasive procedure had a low overall complication rate of 6.86%, with no severe complications reported, and resulted in minimal hemoglobin loss, indicating a safe profile compared to conventional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mini-Perc for Renal Stones-A Single Center Experience and Literature Review. Cauni, VM., Dragutescu, M., Mihai, B., et al.[2023]

Ultra-mini-percutaneous nephrolithotomy (UMP) is highly effective for treating renal stones up to 20 mm, achieving complete stone fragmentation in 95% of patients and a stone-free status of over 99% at two weeks follow-up.

The procedure is safe, with no significant postoperative complications reported, and it requires a shorter operative time (average 39.7 minutes) and a brief hospital stay (average 22.3 hours), making it a favorable alternative to traditional methods like shock wave lithotripsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-mini-percutaneous nephrolithotomy: A minimally-invasive option for percutaneous stone removal. Agrawal, MS., Agarwal, K., Jindal, T., et al.[2022]

Mini-PCNL, which uses smaller tract sizes (4.8 to 22 F), has been shown to reduce complications and hospital stays while allowing for less trauma and avoiding nephrostomy tubes, making it a safer option for treating renal stones.

Despite longer operative times, mini-PCNL techniques, especially with advancements in laser lithotripsy and active suction, show promise in improving stone clearance rates, particularly for larger stones, although stone-free rates may still be sub-optimal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Stone Surgery: Current Status of Miniaturized Percutaneous Nephrolithotomy. DiBianco, JM., Ghani, KR.[2021]

In a study of 89 Vietnamese patients with recurrent kidney stones, miniaturized percutaneous nephrolithotomy (mini-PCNL) demonstrated a high early stone-free rate of 89.9%, increasing to 94.4% after one month, indicating its efficacy in treating this condition.

The procedure was found to be safe, with a low incidence of serious complications; however, some patients experienced secondary bleeding and infections, highlighting the need for careful monitoring post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updated evidence of the safety and efficacy of the miniaturized percutaneous nephrolithotomy with holmium laser lithotripsy for the treatment of recurrent nephrolithiasis. Nguyen, MA., Phan, TL., Vo, HL., et al.[2022]

In a systematic review of five studies, including three randomized controlled trials, vacuum-assisted sheaths significantly improved the stone-free rate (SFR) in minimally invasive percutaneous nephrolithotomy (MPCNL) compared to conventional sheaths, indicating better efficacy in treating kidney stones.

The use of vacuum-assisted sheaths also reduced the postoperative infection rate and led to shorter operative times, enhancing both the safety and efficiency of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of vacuum-assisted sheaths and normal sheaths in minimally invasive percutaneous nephrolithotomy: a systematic review and meta-analysis. Zhu, L., Wang, Z., Zhou, Y., et al.[2022]

The 'mini-perc' technique of percutaneous nephrolithotomy using a 14-Fr peel-away sheath demonstrated an immediate stone free rate of 80.6%, indicating its efficacy in removing pyelocaliceal stones.

The procedure was found to be safe, with only one major complication (arterial bleeding) in a patient with pre-existing liver cirrhosis, which was successfully managed, and the average hospital stay was about 4 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The "mini-perc" technique of percutaneous nephrolithotomy with a 14-Fr peel-away sheath: 3-year results in 72 patients. Sung, YM., Choo, SW., Jeon, SS., et al.[2018]

Mini-percutaneous nephrolithotomy, using a smaller 13F ureteroscopy sheath, aims to lower the morbidity associated with standard percutaneous nephrolithotomy while still effectively removing kidney stones.

This technique may help prevent the unnecessary deferral to less effective procedures, potentially reducing the overall number of treatments and healthcare costs for patients with renal calculi.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mini-percutaneous nephrolithotomy. Chan, DY., Jarrett, TW.[2016]

Citations

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Data From a Prospective, Randomized Clinical Trial

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In our study, mPCNL was associated with good outcomes in patients with NLUTD. The 3-month SFR achieved with mPCNL (37.5%) was comparable to that of sPCNL (38.2 ...

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This study aimed to assess the outcomes of mini-PCNL and RIRS in the treatment of high-density kidney stones measuring 10–20 mm in the lower calyceal region.

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The median access duration, fluoroscopy duration, and hospital length of stay were 271.7 seconds, 14.79 seconds, and 6.3 days, respectively. The ...

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Safety and efficacy of total tubeless mini-PCNL ... - BMC Urology

Percutaneous nephrolithotomy (PCNL) is the first-line treatment for renal stones ≥ 20 mm in size and is considered an alternative treatment ...